Clinical Data Management Specialist

hace 1 semana

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

Job Title: Senior Clinical Data Manager/Principal Clinical Data Manager

Job Summary: We are seeking a highly skilled Senior Clinical Data Manager/Principal Clinical Data Manager to join our team at Precision Medicine Group. As a key member of our data management team, you will be responsible for managing all aspects of clinical trial data management processes from study start-up to post-database lock for assigned projects.

Key Responsibilities:

  1. Oversee primary data management activities for assigned clinical projects, ensuring continuity, responsiveness, and timely completion of tasks.
  2. Develop and implement data entry guidelines, train staff, and ensure data quality.
  3. Perform quality control of data entry and provide input on project timelines.
  4. Assess resource needs for assigned projects and ensure data management deadlines are met.
  5. Develop CRF specifications from clinical study protocols and coordinate reviews with stakeholders.
  6. Build and maintain clinical databases, conduct database build UAT, and oversee overall quality.
  7. Develop edit check specifications and manual data review specifications.
  8. Create, revise, and maintain data management documentation and oversee completeness of the Trial Master File.
  9. Train clinical research personnel on study-specific CRF, EDC, and project-related items.
  10. Review and query clinical trial data according to the Data Management Plan.
  11. Perform line listing data review and run patient and study level status and metric reporting.
  12. Perform medical coding and coordinate SAE/AE reconciliation.
  13. Liaise with third-party vendors and assist with SAS programming and quality control.
  14. Identify and troubleshoot operational problems and participate in the development of SOPs and process documentation.
  15. Attend strategy meetings, bid defenses, and present software demonstrations/trainings.

Qualifications:

  1. Bachelor's degree and/or related experience.
  2. Proven experience as a Lead Data Manager for a Clinical Research Organisation.
  3. Proficiency in Microsoft Office and clinical database management systems.
  4. Strong leadership, communication, and organizational skills.
  5. Professional use of the English language, both written and oral.

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